Back to resultsLATERA-OFFICE Study
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal Implant
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction focused on measuring nasal valve collapse, absorbable nasal implant
Eligibility Criteria
Inclusion Criteria:
- The subject has Nasal Obstruction Symptom Evaluation (NOSE) score ≥55.
- The subject has dynamic lateral nasal wall insufficiency as confirmed by positive modified Cottle maneuver.
- The subject is ≥18 years of age.
- The subject is willing and able to provide informed consent and comply with the study protocol.
- The subject is seeking treatment for nasal airway obstruction due to nasal valve collapse (NVC) and is willing to undergo an in-office nasal implant procedure alone or with a turbinate reduction procedure.
- The subject has appropriate nasal and facial anatomy to receive the Latera Implant.
- The subject agrees to follow-up examinations through 12 months post operatively.
- The subject has failed to benefit from appropriate maximal medical management [eg, nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or tolerability.
Exclusion Criteria:
- The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty.
- The subject has had rhinoplasty within the past 12 months.
- The subject is planning to have other concurrent rhinoplasty procedure.
- The subject is planning to have other rhinoplasty procedures or will use external dilators within 12 months after the index procedure.
- The subject has had septoplasty and/or inferior turbinate reduction within the past 6 months.
- The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
- The subject plans to have any surgical or nonsurgical treatment of their nasal valve, other than the index procedure, within 12 months of the study.
- The subject has a permanent Implant or dilator in the nasal area.
- The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
- The subject currently has active nasal vestibulitis.
- The subject has a history of nasal vasculitis.
- The subject is a chronic systemic steroid or recreational intranasal drug user.
- The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
- The subject has polyps or pathology (ie, septal deviation) other than turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
- The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
- The subject has a known or suspected allergy to polylactide polymer (PLA) or other absorbable materials.
- The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could predispose the subject to poor wound healing.
- The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
- The subject is not a candidate for procedures conducted under local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.
- Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.
Sites / Locations
- Beverly Hills Aesthetic Surgical Institute
- Alessi Institute For Facial Plastic Surgery
- ENT Assoc. of South Florida
- The Center for Sinus, Allergy, & Sleep Wellness
- ENT of Georgia
- Chicago Nasal & Sinus Center
- Madison ENT & Facial Plastic Surgery
- Collin County ENT
- Ogden Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Latera Implant
Arm Description
Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
Outcomes
Primary Outcome Measures
Efficacy: Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Safety: Procedure- and/or Device-related Adverse Events
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Secondary Outcome Measures
Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms.
Subject Satisfaction Questionnaire
Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.
Procedure and Device-related Adverse Events
Number of participants who experience procedure- or device-related adverse events.
Full Information
NCT ID
NCT02964312
First Posted
November 11, 2016
Last Updated
August 20, 2020
Sponsor
Spirox, Inc.
Collaborators
New Arch Consulting
1. Study Identification
Unique Protocol Identification Number
NCT02964312
Brief Title
LATERA-OFFICE Study
Official Title
Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OFFICE) Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
August 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spirox, Inc.
Collaborators
New Arch Consulting
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without concurrent turbinate reduction procedures in an office setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
Keywords
nasal valve collapse, absorbable nasal implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm intervention with pre/post comparison for treatment response.
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latera Implant
Arm Type
Other
Arm Description
Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
Intervention Type
Device
Intervention Name(s)
Nasal Implant
Intervention Description
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
Primary Outcome Measure Information:
Title
Efficacy: Percent of Treatment Responders
Description
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time Frame
6 months
Title
Safety: Procedure- and/or Device-related Adverse Events
Description
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of Treatment Responders
Description
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time Frame
1, 3, 12, 18, and 24 months post procedure.
Title
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
Description
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms.
Time Frame
1, 3, 6, 12, 18, and 24 months post procedure
Title
Subject Satisfaction Questionnaire
Description
Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.
Time Frame
6 months
Title
Procedure and Device-related Adverse Events
Description
Number of participants who experience procedure- or device-related adverse events.
Time Frame
After 6 months and up to 12 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has Nasal Obstruction Symptom Evaluation (NOSE) score ≥55.
The subject has dynamic lateral nasal wall insufficiency as confirmed by positive modified Cottle maneuver.
The subject is ≥18 years of age.
The subject is willing and able to provide informed consent and comply with the study protocol.
The subject is seeking treatment for nasal airway obstruction due to nasal valve collapse (NVC) and is willing to undergo an in-office nasal implant procedure alone or with a turbinate reduction procedure.
The subject has appropriate nasal and facial anatomy to receive the Latera Implant.
The subject agrees to follow-up examinations through 12 months post operatively.
The subject has failed to benefit from appropriate maximal medical management [eg, nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or tolerability.
Exclusion Criteria:
The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty.
The subject has had rhinoplasty within the past 12 months.
The subject is planning to have other concurrent rhinoplasty procedure.
The subject is planning to have other rhinoplasty procedures or will use external dilators within 12 months after the index procedure.
The subject has had septoplasty and/or inferior turbinate reduction within the past 6 months.
The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
The subject plans to have any surgical or nonsurgical treatment of their nasal valve, other than the index procedure, within 12 months of the study.
The subject has a permanent Implant or dilator in the nasal area.
The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
The subject currently has active nasal vestibulitis.
The subject has a history of nasal vasculitis.
The subject is a chronic systemic steroid or recreational intranasal drug user.
The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
The subject has polyps or pathology (ie, septal deviation) other than turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
The subject has a known or suspected allergy to polylactide polymer (PLA) or other absorbable materials.
The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could predispose the subject to poor wound healing.
The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
The subject is not a candidate for procedures conducted under local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.
Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Sidle, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beverly Hills Aesthetic Surgical Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Alessi Institute For Facial Plastic Surgery
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
ENT Assoc. of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
The Center for Sinus, Allergy, & Sleep Wellness
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
ENT of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Chicago Nasal & Sinus Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Madison ENT & Facial Plastic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Collin County ENT
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Ogden Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31254279
Citation
Sidle DM, Stolovitzky P, Ow RA, Silvers S, Matheny K, Bikhazi N, Wani M, Scurry WC, Most SP. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope. 2020 May;130(5):1132-1137. doi: 10.1002/lary.28151. Epub 2019 Jun 28.
Results Reference
result
PubMed Identifier
29756407
Citation
Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. 2018 Nov;128(11):2483-2489. doi: 10.1002/lary.27242. Epub 2018 May 14.
Results Reference
result
PubMed Identifier
33853139
Citation
Sidle DM, Stolovitzky P, O'Malley EM, Ow RA, Nachlas NE, Silvers S. Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. 2021 Oct;37(5):673-680. doi: 10.1055/s-0041-1726464. Epub 2021 Apr 14.
Results Reference
derived
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LATERA-OFFICE Study
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